RecruitingACTRN12614000798662

Retrospective/prospective Clinical Study of AcrySof (Registered Trademark) IQ ReSTOR (Registered Trademark) +2.5 D Multifocal Toric Intraocular Lenses, which will collect information about the safety and effectiveness (how the lens works) from participants who have had cataract surgery and been implanted with these intraocular lenses

The primary objective of the study is to characterize the safety (adverse events) and effectiveness (residual cylinder and visual acuity) of the ACRYSOF IQ ReSTOR +2.5 D Multifocal Toric IOL in primary eyes of subjects at least 3 months and no more than 14 months after IOL implantation. The primary eye is defined as the eye of a subject that qualifies with the most recent implantation of the study lens (ACRYSOF IQ ReSTOR +2.5 D Multifocal Toric IOL Models SV25T2- SV25T5).


Sponsor

Alcon Laboratories (Australia) Pty Ltd

Enrollment

42 participants

Start Date

Jul 21, 2014

Study Type

Observational

Conditions

Summary

This is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data and a prospective postoperative visit conducted at least 3 months but not more than 14 months after IOL implantation. The study is unmasked with no control group, no randomization and will include approximately 4 sites. The primary objective of the study is to characterize the safety (adverse events) and effectiveness (residual cylinder and visual acuity) of the AcrySof IQ ReSTOR +2.5 D Multifocal Toric IOL in primary eyes of subjects at least 3 months and no more than 14 months after IOL implantation. The primary eye is defined as the eye of a subject that qualifies with the most recent implantation of the study lens (AcrySof IQ ReSTOR +2.5 D Multifocal Toric IOL Models SV25T2-SV25T5)


Eligibility

Sex: Both males and femalesMin Age: 21 Yearss

Plain Language Summary

Simplified for easier understanding

This study collects information about how well a specific type of multifocal toric intraocular lens (AcrySof IQ ReSTOR +2.5D) works and how safe it is in patients who have already had it implanted during cataract surgery. A toric lens corrects astigmatism, while a multifocal lens helps with both near and distance vision. You may be eligible if: - You are 21 years or older - You have already had the AcrySof IQ ReSTOR +2.5D Multifocal Toric IOL implanted during cataract surgery - At least 3 months but no more than 14 months have passed since your surgery - You are willing to come in for a follow-up visit You may NOT be eligible if: - You had a different IOL implanted before this specific lens - You had an eye infection or eye surgery around the time of your cataract operation - You have conditions like corneal dystrophy, severe dry eye, retinal disease, or diabetic eye problems - You have had type 1 or 2 diabetes for more than 5 years - You were pregnant at the time of surgery or are currently pregnant - You are currently participating in another clinical study Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

A: The AcrySof IQ ReSTOR +2.5 D Multifocal Toric Intraocular Lens is implanted during cataract surgery to replace the cataractous lens B: Once as the AcrySof IQ ReSTOR +2.5 D Multifocal Toric Intrao

A: The AcrySof IQ ReSTOR +2.5 D Multifocal Toric Intraocular Lens is implanted during cataract surgery to replace the cataractous lens B: Once as the AcrySof IQ ReSTOR +2.5 D Multifocal Toric Intraocular Lens stays in the eye for life of the patient


Locations(1)

NSW,VIC, Australia

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ACTRN12614000798662


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